BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV 2.0 WITH SHUNTASSISTANT 20

    MDR report key: 17494263 · Received August 9, 2023

    Report

    Report Number
    3004721439-2023-00225
    Event Type
    Injury
    Date Received
    August 9, 2023
    Date of Event
    July 8, 2023
    Report Date
    September 14, 2023
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    PMA / PMN Number
    K161853
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - H4. CORRECTED INFORMATION - B5, D1, D9, D4 (MATERIAL #) MANUFACTURING SITE EVALUATION: VISUAL INSPECTION: IN THE FIRST STEP OF OUR INVESTIGATION, WE PERFORMED A VISUAL INSPECTION OF THE PRODUCT. WE HAVE CHECKED FOR POSSIBLE DAMAGE, DEFORMATION OF THE HOUSING, DEPOSITS OR OTHER ABNORMALITIES. THE FOLLOWING OBSERVATIONS WERE MADE DURING THE VISUAL INSPECTION: FOREIGN CATHETER, OTHERWISE NO ABNORMALITIES. PERMEABILITY TEST: THE PERMEABILITY TEST WAS PERFORMED AT A HYDROSTATIC PRESSURE DIFFERENCE OF THE PRESSURE SETTING OF THE PROGAV 2.0 SHUNT SYSTEM UPON RECEIPT PLUS 30 CMH2O IN THE HORIZONTAL DIRECTION OF FLOW. THE TEST SHOWED THAT THE PROGAV 2.0 SHUNT SYSTEM IS PERMEABLE. COMPUTER CONTROL TEST: TO CHECK THE FLOW RATE OF THE VALVES, THE VALVES WERE TESTED ON A MIETHKE COMPUTER CONTROLLED TESTING APPARATUS AND PASSED THE STANDARD TEST. THE FLOW OF THE TEST LIQUID WAS REDUCED STEP BY STEP FROM 60 ML/H TO 5 ML/H (IN ACCORDANCE WITH ISO 7197). DISTILLED WATER WAS USED AS THE TEST-LIQUID. THE RESULTING PRESSURE WAS MEASURED. THE COMPUTER CONTROLLED TEST SHOWED THE OPENING PRESSURE OF THE PROGAV 2.0, AT A REFERENCE FLOW RATE OF 20 ML/H IN A HORIZONTAL POSITION, TO BE 12.01 CMH2O. THIS IS WITHIN THE SPECIFIED TOLERANCE OF 12 CMH2O ± 3 CMH2O. ADDITIONALLY, THE SHUNTASSISTANT WAS TESTED ACCORDING TO STANDARD PROCEDURE IN THE VERTICAL POSITION. THE RESULTS INDICATED THAT AT A REFERENCE FLOW OF 20 ML/H IN THE VERTICAL POSITION, THE SHUNTASSISTANT HAD A PRESSURE OF 20.72 CMH2O. THIS IS WITHIN THE SPECIFIED TOLERANCE OF 20 CMH2O -2 / +4 CMH2O. ADJUSTABILITY TEST: IN THIS STEP, IT WAS INVESTIGATED WHETHER THE ADJUSTABLE PROGAV 2.0 CAN BE SUCCESSFULLY SET TO EACH SPECIFIED PRESSURE SETTING. IT WAS CHECKED WHETHER THE VALVE IS FULLY ADJUSTABLE WITHIN THE FULL RANGE OF SPECIFIED PRESSURE SETTINGS ( IN INCREMENTS OF 5 CMH2O). THE PROGAV 2.0 WAS FOUND TO BE ADJUSTABLE TO ALL PRESSURE SETTINGS. THE SHUNTASSISTANT IS A FIXED PRESSURE VALVE, THEREFORE THE ADJUSTABILITY TEST IS INAPPLICABLE. BRAKING FORCE AND BRAKE FUNCTION TEST: THE BRAKING FORCE AND BRAKE FUNCTION TEST INVESTIGATES WHETHER THE BRAKE FUNCTION OF THE ADJUSTABLE VALVES IS PRESENT AND HOW MUCH FORCE MUST BE EXERTED ON THE HOUSING TO RELEASE THE ROTOR TO ADJUST THE VALVES USING THE INTEGRATED MAGNET OF A SPECIFIC MEASUREMENT APPARATUS OF BRAKING FORCE. THE BRAKING FORCE OF THE PROGAV 2.0 WAS WITHIN THE SPECIFIED TOLERANCE AND THE BRAKE FUNCTION OPERATED AS EXPECTED. INTERNAL INSPECTION OF PRODUCT: IN ORDER TO VERIFY WHETHER THE INVESTIGATED SHUNT SYSTEM WAS COMPROMISED BY THE KNOWN RISKS OF HYDROCEPHALUS THERAPY, E.G. BY A BUILD-UP OF NATURAL SUBSTANCES (PROTEIN, BLOOD, OR TISSUE PARTICLES) IN THE CEREBROSPINAL FLUID, THE VALVES ARE FINALLY OPENED WITH A SPECIAL TOOL. AFTER DISMANTLING OF THE VALVES, NO DEPOSITS WERE FOUND IN BOTH VALVES. FOR VISIBILITY OF POSSIBLE PROTEINS/DEPOSITS, THE PROGAV 2.0 SHUNT SYSTEM WAS COLOURED BY USING A COLOURING SOLUTION. [COLOURING SOLUTION CONSISTING OF COOMASSI BRILLIANT BLUE R MIXED WITH 0.6% ETHANOL AND DISTILLED WATER]. RESULTS: FOR THE SAKE OF THOROUGHNESS AND TRANSPARENCY, WE WOULD LIKE TO POINT OUT THAT AN PERMEABILITY TEST WERE ALREADY CARRIED OUT AFTER THE REVISION AT THE HOSPITAL. BASED ON OUR INVESTIGATION RESULTS, AT THE TIME OF OUR INVESTIGATION, WE CANNOT FIND ANY MALFUNCTION. THE CAUSE OF THE AFOREMENTIONED FUNCTIONAL IMPAIRMENT IS NOT KNOWN TO US AT THE TIME OF THE EXAMINATION. WE CAN EXCLUDE A DEFECT AT THE TIME OF RELEASE. THE SHUNT SYSTEM MET ALL SPECIFICATIONS OF THE FINAL INSPECTION WHEN RELEASED FROM CHRISTOPH MIETHKE GMBH & CO. KG. FURTHER ACTIONS: FROM OUR POINT OF VIEW, NO FURTHER REGULATORY ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX413T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023. THE COMPLAINT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. NO PATIENT INFORMATION WAS SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (#FX441T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. NO PATIENT INFORMATION WAS SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1543898 PROGAV 2.0 WITH SHUNTASSISTANT 20 HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FX413T 20052781

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention